A single value or a list of multiple coded values, specifying one or more distinct colors that approximate of the color(s) of distinct areas of the solid dosage form, such as the different sides of a tablet or one-part capsule, or the different halves of a two-part capsule.
Imprints on the dosage form, regardless of their color, are not considered when assigning an SPLCOLOR.
Bands on banded capsules, regardless of their color, are not considered when assigning an SPLCOLOR.
If more than one color exists on a particular side or half, then the most predominant color on that side or half is recorded.
If the gelatin capsule shell is colorless and transparent, use the predominant color of the contents that appears through the colorless and transparent capsule shell.
A characteristic of an oral solid dosage form of a medicinal product, specifying the two dimensional representation of the solid dose form, in terms of the outside perimeter of a solid dosage form when the dosage form, resting on a flat surface, is viewed from directly above, including slight rounding of corners.
SPLSHAPE does not include embossing, scoring, debossing, or internal cut-outs.
SPLSHAPE is independent of the orientation of the imprint and logo.
<Insert reference here to the SPLSHAPE of a capsule>
A characteristic of an oral solid dosage form of a medicinal product, specifying the longest single dimension of the solid dosage form as a physical quantity in the dimension of length (e.g., 3 mm).
The length is always in millimeters and should be rounded to the nearest whole millimeter.
SPLSIZE for a rectangular shaped tablet is the length and SPLSIZE for a round shaped tablet is the diameter.
A characteristic of an oral solid dosage form of a medicinal product, indicating whether it has one or more coatings, such as sugar coating, film coating, or enteric coating.
Only coatings to the external surface or the dosage form should be considered (for example, coatings to individual pellets or granules inside a capsule or tablet are excluded from consideration).
Scoring A characteristic of an oral solid dosage form of a medicinal product, specifying the number of equal pieces that the solid dosage form can be divided into using score line(s).
A characteristic of an oral solid dosage form of a medicinal product to describe whether or not the medicinal product has a mark or symbol appearing on it for easy and definite recognition.
Score lines, letters, numbers, and internal and external cut-outs are not considered marks or symbols. .
Imprint Code
To record text, begin on either side or part of the dosage form. Start at the top left and progress as one would normally read a book. Enter a semicolon to show separation between words or line divisions.
Solid Oral Dose Form Imprinting Characteristics
A characteristic of an oral solid dosage form of a medicinal product, specifying the number of equal pieces that the solid dosage form can be divided into using score line(s).
To record text, begin on either side or part of the dosage form. Start at the top left and progress as one would normally read a book. Enter a semicolon to show separation between words or line divisions.